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Starting point of the general part of the following article dealing with cleaning validation is a more general description of procedures for planning and conducting cleaning validation studies. Addressed are expectations from regulatory bodies, possibly occurring contamina-tions or impurities, the needs for documentation and the sequence of steps in validation studies. Prerequisites for the analytics and examples for testing parameters are followed by considerations for the choice of sampling points.
The second part focuses on plasma products containing proteins in the source material as well as in the final product. Advantages and limits for rinse and swab sampling methods are men-tioned and lead to the subject of appropriate analytical testing for proteins. Concluding approaches and strategies for setting acceptance criteria are outlined with focus on protein residues.